Safety and Tolerability of TASIS-Peanut (Targeted Allergen Specific Immunotherapy within the Skin) patch for the Treatment of Peanut Allergy

TASIS-花生（皮肤内靶向过敏原特异性免疫疗法）贴剂治疗花生过敏的安全性和耐受性

• 批准号: 10551184
• 负责人: Samirkumar Patel
• 金额: $ 29.98万
• 依托单位: MOONLIGHT THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-10 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10551184
• 关键词: Accidents; Adult; Adverse reactions; Affect; Age; Agreement; Allergens; Allergic; Allergy to peanuts; Anaphylaxis; Cessation of life; Child; Clinic; Clinical; Clinical Trials; Collaborations; Critiques; Cutaneous; Data; Dendritic Cells; Dermal; Diet; Documentation; Dose; Equation; Europe; Evaluation; FDA approved; Family; Feedback; Food Hypersensitivity; Friends; Funding; Gills; Goals; Government; Grant; Hypersensitivity; Immune system; Immunotherapy; Investigation; Lead; Letters; Life; Malnutrition; Marketing; Mind; Miniature Swine; Mus; National Institute of Allergy and Infectious Disease; Needles; Painless; Pamphlets; Patients; Pediatric Hospitals; Pediatrics; Persons; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Phase III Clinical Trials; Population; Procedures; Production; Proteins; Protocols documentation; Quality of life; Reporting; Reproducibility; Research; Research Personnel; Risk Reduction; Running; Safety; Site; Skin; Small Business Innovation Research Grant; Statistical Data Interpretation; System; Technology; Therapeutic; Time; Universities; Visit; Work; clinical research site; desensitization; efficacy evaluation; first-in-human; immunoregulation; invention; medical schools; meetings; mid-career faculty; minimally invasive; mouse model; novel; novel therapeutics; peace; phase I trial; pre-clinical; preclinical development; programs; safety assessment; skin patch; social; trial planning

The following contains proprietary/privileged information that Moonlight Therapeutics requests not be released to persons outside the government, except for purposes of review and evaluation Safety and Tolerability of TASIS-Peanut (Targeted Allergen Specific Immunotherapy within the Skin) patch for the Treatment of Peanut Allergy Food allergies affect 30 million people in the USA and 17 million in Europe. Six million children, roughly 1 in 13, in the USA have at least one food allergy; this equates to at least 1 in every classroom. Currently, there is only one FDA approved therapy in the USA for food allergies. Food allergies are expected to grow 10% annually until at least 2022. It is also common for someone to have more than one allergy. This is a growing, underserved global market that has few treatment options. A meaningful initial therapy would be one that reduces the chance for anaphylactic reaction after accidental exposure. Such a therapy will help bring peace of mind to families, allow for children affected by food allergies to have better quality of life, feel less socially out casted and most importantly reduce the potential for death from accidental procedure. Moonlight Therapeutics is developing a targeted way to administer allergens into the top skin layers to desensitize an allergic patient, called Targeted Allergen Specific Immunotherapy in the Skin (TASIS). Delivery is achieved using microneedles applied to the skin for a few minutes, which are minimally invasive and painless. Importantly microneedles can deliver into topmost skin layers with high precision and reproducibility. Because TASIS delivers small doses in the top and superficial skin layers, the approach is expected to produce little to no systemic adverse reactions. The company's first treatment is focused on peanut allergy and is called TASIS-Peanut. We have demonstrated efficacy of our approach in a pre-clinical mouse model of peanut sensitization. This Fast-track (Phase1/Phase2) SBIR grant (U44) application is for a Phase 1 safety and tolerability study to be conducted in partnership between the company and collaborating clinical research sites. The objective of the U44 Fast- track grant is to prepare documents for (grant PHASE 1) and conduct (grant PHASE 2) a Phase 1 clinical trial to assess the safety and tolerability of TASIS-Peanut in peanut allergic children and adults. The Phase 2 portion of the grant also includes aims geared towards production of TASIS-Peanut for the clinical trial. The company currently has a R42 Fast-track grant for the pre-clinical development of TASIS-Peanut. Overall this grant will enable evaluation of the safety and tolerability of TASIS-Peanut in a first-in-human clinical trial. It will set the stage for evaluation of efficacy in a Phase 2 clinical trial.

以下内容包含Moonlight Therapeutics要求不得向政府以外的人员发布的专有/特权信息，除非出于以下目的 审查和评价 TASIS-花生的安全性和耐受性（针对过敏原特异性免疫疗法， 花生过敏症的治疗方法 食物过敏影响着美国3000万人和欧洲1700万人。在美国，有600万儿童， 至少有一种食物过敏;这相当于每个教室至少有一种。目前，只有一个FDA批准 在美国治疗食物过敏。食物过敏预计每年增长10%，直到至少2022年。也是 对一种以上过敏的人很常见这是一个不断增长、服务不足的全球市场， 选项.一个有意义的初始治疗将是一个减少过敏反应的机会后，意外 exposure.这样的治疗将有助于给家庭带来心灵的平静，让受食物过敏影响的儿童能够 更好的生活质量，更少的社会排斥感，最重要的是减少意外死亡的可能性。 procedure. 月光治疗公司正在开发一种有针对性的方法，将过敏原注入皮肤表层， 过敏患者，称为皮肤中的靶向过敏原特异性免疫疗法（TASIS）。交付使用 微针应用于皮肤几分钟，这是微创和无痛的。重要的微针 可以以高精度和可重复性输送到最表层。因为TASIS在顶部提供小剂量 和浅表皮肤层，该方法预计产生很少或没有全身不良反应。公司 第一种治疗集中在花生过敏，被称为TASIS-花生。我们已经证明了我们的方法的有效性， 花生致敏的临床前小鼠模型。 此快速通道（第1/2期）SBIR补助金（U44）申请用于1期安全性和耐受性研究， 在公司和合作临床研究中心之间进行合作。U44的目标是快速- 跟踪补助金是准备（第1阶段补助金）和进行（第2阶段补助金）1期临床试验的文件， 评估TASIS-花生在花生过敏儿童和成人中的安全性和耐受性。补助金的第二阶段 还包括面向生产TASIS-花生的临床试验的目标。该公司目前拥有一台R42 TASIS-Peanut临床前开发的快速通道赠款。 总的来说，这笔赠款将使TASIS-花生在首次人体临床试验中的安全性和耐受性得到评估。它将 为II期临床试验的疗效评估奠定基础。